Colestrim/Colestrim Supra

Colestrim/Colestrim Supra

fenofibrate

Manufacturer:

Mega Lifesciences

Distributor:

Maxxcare
Concise Prescribing Info
Contents
Fenofibrate
Indications/Uses
Adjunctive therapy to diet for reduction of elevated LDL-C, total-C, triglycerides & Apo-B, & increase of HDL-C in adult w/ primary hypercholesterolemia or mixed dyslipidemia. Adjunctive therapy to diet in adult w/ severe hypertriglyceridemia (Fredrickson types IV & V hyperlipidemia).
Dosage/Direction for Use
Adult Primary hypercholesterolemia or mixed hyperlipidemia 145 or 160 mg/day. Hypertriglyceridemia Individualized dosage. Adjust if necessary following repeat lipid determination at 4-8 wk intervals. Initial dose: 145 mg/day. Max: 145 mg once daily.
Administration
Film-coated tab: Should be taken with food.|Tab: May be taken with or without food.
Contraindications
Hypersensitivity to fenofibrate or fenofibric acid. Severe renal impairment. Active liver disease. Preexisting gallbladder disease. Lactation.
Special Precautions
145-mg tab: Treat secondary cause of hypercholesterolemia prior to initiation. Ascertain whether the hyperlipidaemia is of primary or secondary nature in concurrent use w/ estrogens or estrogen-containing contraceptives. May increase transaminase levels. Potential pancreatitis occurrence. Muscle toxicity including rhabdomyolysis may occur; higher incidence in patients w/ history of hypoalbuminemia & renal insufficiency. Interrupt treatment in increased creatinine levels (>50%) & upper limit of normal; measure creatinine during 1st 3 mth after initiation & periodically, thereafter. Not for patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption; fructose intolerance, sucrase-isomaltase insufficiency; allergy to soya lecithin or related products. 160-mg FC tab: Discontinue use w/ blockers, thiazides, estrogens. Determine serum lipid levels periodically during initiation. Avoid use w/ fenofibrate, gemfibrozil & clofibrate. Potential acute hypersensitivity reactions including Stevens-Johnson syndrome & toxic epidermal necrolysis. Thrombocytopenia & agranulocytosis may occur; perform periodic blood counts during 1st 12 mth. Perform regular periodic monitoring of liver function including SGPT duration therapy; discontinue if enzyme levels persist >3 x normal limit. May be associated w/ myopathy. May increase cholesterol excretion into the bile, leading to cholelithiasis; discontinued if gallstones are found. Pregnancy. Childn. Elderly.
Adverse Reactions
Digestive, gastric or intestinal disorders. Moderately elevated levels or serum transaminases.
Drug Interactions
Enhances oral anticoagulant effect of anticoagulants; may increase risk of bleeding. Closely monitor renal function during concomitant use of cyclosporin; discontinue w/ severe alternation of laboratory parameters. Increased risk of serious muscle toxicity in concomitant use w/ HMG-CoA reductase inhibitors & other fibrates. Carefully monitoring in concomitant CYP2C19, CYP2A6 & especially CYP2C9 metabolised drugs w/ narrow therapeutic index. 160-mg FC tab: Discontinue blockers, thiazides, estrogens for known hypertriglyceridemia exacerbation; Pancreatitis may occur in patients taking fenofibrate, gemfibrozil & clofibrate.
ATC Classification
C10AB05 - fenofibrate ; Belongs to the class of fibrates. Used in the treatment of hyperlipidemia.
Presentation/Packing
Form
Colestrim film-coated tab 160 mg
Packing/Price
30's
Form
Colestrim Supra tab 145 mg
Packing/Price
3 × 10's
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